Evidence map›Paper›PMID 32063024›Full record

ReviewClinical trials (London, England)2020

A review of available software for adaptive clinical trial design.

Michael John Grayling, Graham Mark Wheeler

Open access · hybridAbstract readReview
In one paragraph

Review in Clinical trials (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
0.7field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 4 citations in OpenAlex.

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  6. Building and Sustaining Open-Source Medical Device Projects.IEEE transactions on bio-medical engineering · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors at 2 institutions in 1 country.

Michael John GraylingMRC Biostatistics Unit, University of Cambridge, Cambridge, UK.ORCID 0000-0002-0680-6668
Graham Mark WheelerCancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.ORCID 0000-0002-3254-5991
Cancer Research UK · GBUniversity of Cambridge · GB

Funding

Cancer Research UKMedical Research Council MC_UU_00002/3
6 · The paper itself

Abstract

BACKGROUND/

aimsThe increasing cost of the drug development process has seen interest in the use of adaptive trial designs grow substantially. Accordingly, much research has been conducted to identify barriers to increasing the use of adaptive designs in practice. Several articles have argued that the availability of user-friendly software will be an important step in making adaptive designs easier to implement. Therefore, we present a review of the current state of software availability for adaptive trial design.

methodsWe review articles from 31 journals published in 2013-2017 that relate to methodology for adaptive trials to assess how often code and software for implementing novel adaptive designs is made available at the time of publication. We contrast our findings against these journals' policies on code distribution. We also search popular code repositories, such as Comprehensive R Archive Network and GitHub, to identify further existing user-contributed software for adaptive designs. From this, we are able to direct interested parties toward solutions for their problem of interest.

resultsOnly 30% of included articles made their code available in some form. In many instances, articles published in journals that had mandatory requirements on code provision still did not make code available. There are several areas in which available software is currently limited or saturated. In particular, many packages are available to address group sequential design, but comparatively little code is present in the public domain to determine biomarker-guided adaptive designs.

conclusionsThere is much room for improvement in the provision of software alongside adaptive design publications. In addition, while progress has been made, well-established software for various types of trial adaptation remains sparsely available.

Indexed as

Research DesignSoftwareAdaptive Clinical Trials as TopicBayes TheoremBiomarkersComputer SimulationDose-Response Relationship, DrugHumansSample SizeBiomarkersCodedose escalationgroup sequentialmulti-stagephase I/IIphase II/IIIsample size re-estimation

Identifiers

PMID32063024
PMCPMC7736777
OpenAlexW2949195089

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.